Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018508
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TIS-U-SOL | MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE | 20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML | SOLUTION;IRRIGATION | Prescription | AT | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/19/1982 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/26/2015 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/2015 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/2011 | SUPPL-19 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/14/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1990 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1985 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
TIS-U-SOL
SOLUTION;IRRIGATION; 20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TIS-U-SOL | MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE | 20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML | SOLUTION;IRRIGATION | Prescription | No | AT | 018508 | BAXTER HLTHCARE |
| TIS-U-SOL IN PLASTIC CONTAINER | MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE | 20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML | SOLUTION;IRRIGATION | Prescription | No | AT | 018336 | BAXTER HLTHCARE |